Kornimate/medical-research-clean huggingface dataset:
enhancing a sustainable pharmacy-based immunization program in two states

Conditions: Herpes Zoster; Pneumococcal Infections

Summary: the study's aim is to enhance current immunization activities in community pharmacies through targeting the two most commonly available non-seasonal vaccines in community pharmacies, namely pneumococcal and herpes zoster vaccination services. the study will compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies.

community pharmacies are in a unique position and have potential to help increase immunization rates, especially among those who do not visit their primary care provider regularly. this study seeks to increase the level of pharmacy-based immunization delivery. the study intervention is designed to increase the current level of pharmacy-based immunization delivery and foster practice change to sustain the intervention effect. our intervention combines evidence-based strategies for improving immunization coverage and strategies to overcome system barriers to increase sustainability of the intervention over time. the study will focus on pneumococcal and herpes zoster vaccination services. specific aims include: 1. to compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies. the pre-intervention period will correspond to the intervention period. 2. to compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies. 3. to compare the level of sustainability of immunization services over the period of 6 months after the intervention period ends between the intervention group and the control group. 4. to explore facilitators and barriers to implementing immunization services. 5. to explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.

Eligibility criteria:
inclusion criteria: * alabama and california community pharmacies * must provide in-store prescription-dispensing service * must provide pneumococcal vaccine and/or herpes zoster exclusion criteria: * must have no plan to close or change the ownership in the next 12 months

Keywords: pneumococcal vaccines shingles pharmacy vaccine immunization
single and multiple dose safety, tolerability, pk and food effect study of hec585 in healthy male and female subjects

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the safety, tolerability pharmacokinetic and food effect study of hec585 in healthy male and female subjects


Eligibility criteria:
inclusion criteria: 1. subjects who are willing and are able to provide a written informed consent to participate in the study. 2. without plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. subjects aged between 18 and 45 (both inclusive) years old. 4. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening. 5. subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, chest x-ray and 12-lead electrocardiogram (ecg). exclusion criteria: 1. subjects with a positive serology for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibodies and/or tp antibodies at screening. 2. subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation. 3. known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique. 4. use of any prescription or non-prescription medications within 14 days prior to initial dosing，use of any medications known to inhibit or induce cytochrome p enzyme drug metabolism within 28 days prior to initial dosing. 5. consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 6. positive results from urine drug screen test. 7. history of alcoholism or drink regularly within 3 months prior to the study(defined as alcohol consumption of \> 21 units/week), or positive results from alcohol breath test. 8. regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study. 9. donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. 10. subjects who plan to receive or have had organ transplants. 11. females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 12. subjects who participated in another clinical trial within 3 months prior to initial dosing. 13. any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
3d-printed reconstruction automated matching system predicts size of double-lumen tube: a prospective double-blinded randomized controlled trial

Conditions: Lung Cancer; Lung Diseases; Tracheal Intubation Morbidity; Throat Injury; Bronchus; Injury

Summary: lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients. we have developed an automatic comparison software for 3d reconstruction based on ct data (3dracs). it reconstructs the trachea and bronchus and compares them with the dlt, predicting the most suitable size and depth of the dlt for lung isolation.the aim of this study was to compare whether the use of 3dracs to select a dlt size compared to conventional empirical selection methods could improve incidence of dlt intubation success and reduce airway injury.

lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients undergoing various intra-thoracic procedures. lung isolation is primarily accomplished with a double-lumen tube (dlt) or bronchial blocker. one published study showed that residents with limited experience had a 40% error rate in accurately placing a dlt. the accurate choice of the size of dlt is a prerequisite for good lung isolation.currently, there is lack of proper objective criteria for selecting size of dlt. dlt size selection is estimated empirically using the patient's height and sex, and studies have shown that the size of dlt according ct images of the chest is more accurate than experience. we have developed an automatic comparison software for 3d reconstruction based on ct data (3dracs). it reconstructs the trachea and bronchus and compares them with the dlt, predicting the most suitable size and depth of the dlt for lung isolation. the aim of this study was to compare whether the use of 3dracs to select a dlt size compared to conventional empirical selection methods could improve incidence of dlt intubation success and reduce airway injury.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 75 years. 2. american society of anesthesiologists physical status (asa-ps) i-iii. 3. planned to receive lung resection surgery during lung isolation techniques by using dlt. 4. signed informed written consent. exclusion criteria: the participant experiences any of the following： 1. spinal malformation, 2. expected difficult airway 3. tracheal stenosis 4. tracheal tumor 5. bronchial tumor 6. distorted airway anatomy 7. tumors of the mouth or neck
the durability of early ra disease control after tocilizumab withdrawal: a canadian experience

Conditions: Rheumatoid Arthritis

Summary: patients who participated in the function study (protocol wa19926) will be enrolled in this study. the investigators want to learn how long it takes early rheumatoid arthritis patients who were treated with tocilizumab to require treatment with another biologic medication.


Eligibility criteria:
inclusion criteria: * completed 2 years in the function (wa19926) trial * patient has provided written informed consent and is willing to comply with the requirements of this study protocol exclusion criteria: * requirement for immediate treatment with a biologic therapy following completion of the function (wa19926) trial as per treating physician judgement. * presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of ra

Keywords: tocilizumab early rheumatoid arthritis observational canadian
comparison of operated ruptured and non-ruptured endometriomas

Conditions: Endometrioma; Ruptured Endometrioma; Endometriosis Ovary

Summary: ruptured endometrioma cases were compared with unruptured endometrioma cases.

this study aims to compare the findings in patients who had surgery for ruptured endometrioma with the patients who had an unruptured endometrioma. this study was conducted at republic of turkey ministry of health, health science university etlik zübeyde hanım gynecology training and research hospital infertility clinic and all patients who were operated for endometrioma and had a histopathology report confirming the presence of endometrioma between january 2014 and december 2020 were included. in this study, demographic characteristics, intraoperative findings, laboratory values and follow-up recommendations of two groups compared. the patients' age, presence of sexual activity and/or infertility, gravidity, parity, abortion, history of ectopic pregnancy, accompanying systemic disease, previous operations, drug use, and symptoms were recorded. preoperative and postoperative complete blood count, cancer antigen 125 (ca 125), cancer antigen 19-9 (ca19-9), cancer antigen 15-3 (ca 15-3), carcinoembryonic antigen (cea), alpha fetoprotein (afp), anti mullerian hormone (amh), fibrinogen, c-reactive protein (crp) values of the patients were obtained. patient files, operation notes and laboratory values of the electronic recording system database and the two groups were compared.

Eligibility criteria:
inclusion criteria: * all patients who were operated on in republic of turkey ministry of health, health science university etlik zübeyde hanım gynecology training and research hospital infertility clinic, whose histopathological diagnosis was confirmed as endometrioma, and who did not meet the exclusion criteria, were included in the study. exclusion criteria: * patients who were operated with a prediagnosis of endometrioma and whose pathological diagnosis was different * patients with smoking, alcohol, substance abuse * patients receiving pelvic radiotherapy/chemotherapy * patients with suspected or confirmed malignancies

Keywords: endometrioma rupture endometriosis
quality of life of patients with a history of drug allergy in thailand

Conditions: Quality of Life

Summary: quality of life of patients with a history of drug allergy in thailand will be studied.

thai patients with a history of drug allergy will be evaluated for their quality of life based on drug hypersensitivity quality of life questionnaire (drhy-q; thai version) and the world health organization quality of life instrument (whoqol-bref-thai)

Eligibility criteria:
inclusion criteria: * have a history of drug allergy * at least 18 years of age exclusion criteria: * not be able to understand thai language

Keywords: quality of life
uncertainty in illness in palliative care: an intervention for family caregivers

Conditions: Uncertainty; Advanced Cancer; Family Members; Quality of Life

Summary: background: the increase of chronic diseases has reached an increase in the suffering of advanced diseases and an inability of health care systems to give access to the population that suffers them. in this context are people with advanced cancer who are in palliative care and the family caregivers. uncertainty in illness in palliative care and quality of life are two concepts that are altered in the patient's family caregiver in palliative care. objective: to examine the feasibility and acceptability of a nursing intervention to reduce the uncertainty in illness and improve the quality of life of family caregivers of patients with cancer in palliative care. methodology: phase ii clinical trial, the ratio of recruitment, follow-up of participants as well as satisfaction with the intervention will be evaluated as primary outcomes. as secondary outcomes, the possible effect of the intervention on the uncertainty in illness and the quality of life of the family caregiver will be evaluated. this study will be carry out in a health care institution in medellin-colombia.


Eligibility criteria:
inclusion criteria: * being the person responsible for the care of the person in palliative care most of the time * being over 18 years of age; * caring for a person who has a diagnosis of cancer stage iv, who is receiving palliative treatment for the disease and has an expectation longer than one month of life (determined by the physician) * being able to communicate in spanish. exclusion criteria: * being included in another institutional study of an educational nature * not knowing how to read * caring for another person with cancer before * have a significant cognitive disability

Keywords: uncertainty caregivers palliative care nursing hospice and palliative care nursing
tui-na and oral chinese medicine on koa

Conditions: Knee Osteoarthritis

Summary: the study aims to evaluate the therapeutic effect of the tui-na and oral chinese medicine on the treatment of koa. this is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (koa). after 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. subjects will have 4-week of treatment, and then a 4-week follow-up.

the subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for chinese medicine practitioner (cmp) investigators assessments. the western ontario and mcmaster university osteoarthritis index (womac) and eq-5d-5l will be assessed and filled up at different timepoints. the treatment group will receive both tui-na and study medication and the wait-list control group will receive tui-na alone. cmps will provide consultation under chinese medicine theory. study medication compliance and adverse events will also be assessed at each visit.

Eligibility criteria:
inclusion criteria: 1. of either gender (female must have either sterilization done or menopause) 2. ≥50years of age 3. meet the criteria of koa according to the american college of rheumatology * knee pain, and * any 4 of the following, * ≥ 50 years of age * less than 30 minutes of morning stiffness * crepitus on active motion * bony tenderness * bony enlargement * no palpable warmth of synovium * osteophytes (radiographic findings) 4. with womac score ≥ 39 5. with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission) exclusion criteria: 1. known knee pain caused by infection, malignant or autoimmune diseases 2. knee surgery or arthroscopy in the past year 3. chondroprotective or intra-articular injection in the past 4 months 4. systemic corticoid treatment in the past 4 months 5. taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs 6. subject with uncontrolled hypertension 7. local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks 8. known history of mental disorder 9. known history of serious acute organic disease 10. renal or liver function impairment 11. known allergy to or have drug interaction with the study herb

Keywords: knee osteoarthritis, tui-na, chinese medicine
volociximab in combination with dtic in patients with metastatic melanoma not previously treated with chemotherapy

Conditions: Melanoma; Metastases

Summary: this clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility criteria:
inclusion criteria: * males and females of at least 18 years of age with stage iv or unresectable stage iii non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., il-2 or interferon-alfa). * measurable disease according to response criteria for solid tumors (recist). * eastern cooperative oncology group (ecog) performance status less than or equal to 1. * estimated survival is greater or equal to 4 months. * negative pregnancy test (women of childbearing potential only). * pretreatment laboratory levels that meet specific criteria. * signed informed consent, including permission to use protected health information. exclusion criteria: * prior treatment with m200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies. * prior treatment with dtic, temozolomide, or other chemotherapeutic regimens. * known sensitivity to murine proteins or chimeric antibodies or other components of the product. * use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). * systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of m200. * documented central nervous system (cns) tumor or cns metastasis. * history of thromboembolic events and bleeding disorders within the past year. * medical conditions that may be exacerbated by bleeding.

Keywords: solid tumors metastatic melanoma
a study to assess efficacy and safety of filgotinib in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a multicenter, phase 2, double-blind, placebo-controlled study in subjects with active ankylosing spondylitis (as). a total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. treatment duration will be 12 weeks. each subject will stay in the study for a maximum of 20 weeks (from screening visit to follow-up visit).


Eligibility criteria:
key inclusion criteria: * male or female subjects who are ≥18 years of age on the day of signing informed consent. * diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the modified new york (ny) criteria * have active ankylosing spondylitis with a basdai ≥4 (numeric rating scale \[nrs\] 0-10) and spinal pain ≥4 (0-10 nrs) (based on basdai question 2, see protocol) at screening and baseline. * have had a documented inadequate response to nsaids including cyclooxygenase-2 (cox-2) inhibitors. * if using cdmard therapy, stable dose for at lead 4 weeks prior to baseline. * if using non-drug therapies (including physical therapies), these should be kept stable during screening. * male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol. key exclusion criteria: * use of jak inhibitors, investigational or approved, at any time, including filgotinib; * prior use of more than one tnf inhibitor, at any time. * use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline; * any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening; * use of more than 1 nsaid or cox-2 inhibitor. * contraindication to mri. * history of known or suspected complete ankylosis of the spine. * presence of very poor functional status or unable to perform self-care. * have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening. * administration of a live or attenuated vaccine within 12 weeks prior to baseline.
risk factors for recurrent intussusception successful reduction in pediatric patients

Conditions: Intussusception

Summary: to determine risk factors associated with recurrent intussusception among pediatric patients who have undergone successful reduction at a tertiary care hospital.

this is the prospective observational study. in this study, 78 patients,age \<16 years with diagnosis of intussusception between june 2019 and april 2020 who had successful reduction with either hydrostatic reduction and/or operative reduction in teaching hospital were enrolled in the study. they were followed up to a period of 1 month for recurrence of intussusception. the recurrent cases were thus identified and various variables were compared between recurrent and non-recurrent cases by univariable and multivariable analysis. this prospective observational study was approved by the ethics committees of institutional review board of tribhuvan university, institute of medicine. a standard structured questionnaire was filled by interviewing the patient (if possible) and family members/relatives after taking informed written consent. the questionnaire documented the patient's age, sex, weight, duration of symptoms, presenting symptoms: abdominal pain, excessive cry, vomiting, lethargy, blood in stool, fever, palpable mass, constipation, diarrhoea ,location of mass, enlarged lymph nodes(lns), blood counts and methods of reduction. age of 2 years, weight of 12 kg and duration of symptoms of 48 hours was used to classify patients into two groups

Eligibility criteria:
inclusion criteria: * we included the patients who were diagnosed with intussusception from the age of 0 year to 16 years who received nonoperative and operative reduction as an initial treatment. exclusion criteria: * pediatric patients with spontaneous reduction of hydro-reduction and who required resection and anastomosis as a part of operative procedure were excluded from the study.

Keywords: hydrostatic reduction recurrence pediatrics